1. Field of the Invention
The present invention generally relates to methods, devices and systems for the treatment of urinary incontinence. In particular, the present invention provides methods, devices and systems for supporting the urethra in the female anatomy. More particularly, the present invention provides such treatment in a laparoscopic or a minimally invasive manner.
Urinary incontinence arises in both women and men with varying degrees of severity and from different causes. In men, the condition occurs almost exclusively as a result of prostatectomies which result in mechanical damage to the sphincter. In women, the condition typically arises after pregnancy where musculo-skeletal damage has occurred as a result of inelastic stretching of the structures which support the genitourinary tract. Specifically, pregnancy can result in inelastic stretching of the pelvic floor, the external vaginal sphincter, and most often, the tissue structures which support the bladder and bladder neck region. In each of these cases, urinary leakage typically occurs when a patient""s intra-abdominal pressure increases as a result of stress, e.g. coughing, sneezing, laughing, exercise, or the like.
Treatment of urinary incontinence can take a variety of forms. Most simply, the patient can wear absorptive devices or clothing, which is often sufficient for minor leakage events. Alternatively, or additionally, patients may undertake exercises intended to strengthen the muscles in the pelvic region, or may attempt behavior modification intended to reduce the incidence of urinary leakage. In cases where such noninterventional approaches are inadequate or unacceptable, the patient may undergo surgery to correct the problem. A variety of procedures have been developed to correct urinary incontinence in women. Several of these procedures are specifically intended to support the bladder neck region. For example, sutures, straps, or other artificial structures are sometimes looped around the bladder neck and affixed to the pelvis, the endopelvic fascia, the ligaments which support the bladder, or the like. In other cases, the structures are extended over the pubis and through the abdominal wall. The ends of the structure are then available outside the abdominal wall where they may be tightened and fixed for permanent implantation. Other procedures involve surgical injections of bulking agents, inflatable balloons, or other elements to mechanically support the bladder neck.
Each of these procedures has associated shortcomings. Surgical operations which involve suturing of the tissue structures supporting the urethra or bladder neck region require great skill and care to achieve the proper level of artificial support. In other words, it is necessary to occlude the urethra or support the tissues sufficiently to inhibit urinary leakage, but not so much that normal intentional voiding of urine is made difficult or impossible. Balloons and other bulking agents which have been inserted can migrate or be absorbed by the body. The presence of such inserts can also be a source of urinary tract infections.
For these reasons, it would be desirable to provide improved methods, devices and systems for treating urinary incontinence. In particular, it would be desirable to provide such treatment in a minimally invasive manner, preferably utilizing laparoscopic or a least invasive manner to minimize patient trauma. It would further be desirable to provide treatment methods which reduce the potential to perforate the bladder and avoid puncturing the abdominal wall. It would also be desirable to provide methods and devices which avoid the potential drawbacks of bone anchors, such as infection and osteitis pubis. At least some of these objectives will be met by the methods, devices and systems of the present invention described hereinafter.
2. Description of the Background Art
A method for implanting an artificial sphincter to control urinary incontinence is described in U.S. Pat. No. 5,123,428. The first procedure employs a trocar or laparoscope to insert and position an inflatable balloon in the patient""s space of Retzius. The patient""s anterior bladder is connected to the patient""s abdominal wall by a patch to effectively lengthen and stabilize the urethra. The second procedure is to implant a fluid reservoir and manually-actuable valve subcutaneously and connect them to the balloon in a closed system.
A sling having a web for moving an organ or vessel, and sutures connected to the web for maintaining the organ in its displaced position, are described in U.S. Pat. No. 5,337,736. An implant for suspension of the urinary bladder is described in U.S. Pat. No. 5,840,011.
An insertion apparatus for a female bladder control device is described in U.S. Pat. Nos. 5,618,257 and 5,846,180. The insertion apparatus includes an outer tube for insertion into the urethra of a patient, the outer tube having a retention collar for limiting the depth of insertion of the outer tube.
A surgical instrument and a method for treating female urinary incontinence is described in U.S. Pat. No. 5,899,909. When practicing the method the instrument is manipulated so as to position a tape to form a loop around the urethra. The tape is extended over the pubis and through the abdominal wall where it is tightened. Then, the tape ends are cut at the abdominal wall and the tape is left implanted in the body.
The present invention provides methods, devices, and systems for supporting the urethra in a patient to treat urinary incontinence. Support of the urethra involves forming a loop under the urethra with a structure referred to as a urethral support and applying an upward force with the support to hold the urethra in a more desired position. Such a force may be achieved by securely positioning portions of the urethral support within the abdominal anatomy and applying tension to such portions to support the urethra. The present invention utilizes the space of Retzius within which portions of the urethral support are positioned. Ingrowth by surrounding tissues to the urethral support material provide further stability and such ingrowth, combined with the position of the support, allows sufficient tension to be applied to the support to hold the urethra in place. Placement of such a urethral support is achieved by minimally invasive techniques, such as with the use of laparoscopic instruments. Such techniques allow placement of the urethral support by accessing the space of Retzius through the vaginal wall without penetrating the abdominal wall. Such techniques also avoid perforations of nearby organs, such as the bladder, by utilizing specialized penetration devices.
In one aspect of the present invention, a passageway is created within the abdominal anatomy through which at least a portion of the urethral support is advanced and positioned for implantation. Such a passageway is created to extend from the vagina, through the vaginal wall and body tissue or fat layers, to the space of Retzius generally located between the bladder and the pubic bone. By accessing the space of Retzius through the vagina rather than through the abdominal wall, the procedure is less invasive and traumatic to the patient leaving no visible scars. However, such access requires attention to nearby organs which must be avoided to prevent perforation or damage. This may be achieved with the use of specialized penetration devices.
To begin, a penetration device is inserted through the vaginal wall, comprising an endopelvic fascia layer and a mucosal layer. In one embodiment, the penetration device comprises a Veress-style needle. As the needle is advanced beyond the vaginal wall, through body tissue and fat layers, a plunger guards the needle for atraumatic passage through fatty tissues or along tissue planes. Thus, resilient organs, such as the bladder, are pushed way from the needle by the plunger, avoiding perforation. In addition, the penetration device may include a depth stop which defines a maximum depth of penetration by the penetration device. The depth stop provides a stopping surface which rests against the vaginal wall and prevents further insertion of the needle.
The penetration device typically includes a sheath mounted on the needle so that the sheath is positioned within the passageway as it is created. Thus, the penetration device may then be withdrawn leaving the sheath behind in the passageway formed from the space of Retzius to the vagina. At this point, a blunt dilator is inserted into the sheath to dilate the passageway and a portion of the space of Retzius. The dilator is then exchanged with a delivery catheter which is used to place at least a portion of the urethral support within the space of Retzius.
In another aspect of the present invention, the urethral support comprises a number of embodiments. In one embodiment, the urethral support comprises at least one anchor patch. Typical anchor patches are rectangular in shape and are comprised of a flexible, porous material having at least one side with a frictional surface to prevent slippage between tissue layers. In addition, the anchor patch may have sutures attached, typically at one end of the patch. The anchor patch is then positioned in the passageway so that at least a portion of the patch resides with the space of Retzius and the sutures are positioned such that their free ends exit through at least the endopelvic fascia layer of the vaginal wall. Thus, the patch, including the sutures, extends through the abdominal anatomy to one side of the urethra. Generally, another anchor patch is positioned in the same manner through a second passageway on the opposite side of the urethra. Then, the free ends of the sutures are utilized to provide support under the urethra. For example, the free ends may be fastened to the vaginal wall wherein the anchor patches are adjusted to apply tension to the patches and upward force on the urethra. Alternatively, the sutures may be connected, such as by a band or similar device which is positioned under the urethra for attachment to the suture ends. Again, the anchor patches may then be adjusted to apply tension to the patches and upward force on the urethra.
In another embodiment, the urethral support comprises a sling which is used to form a loop under the urethra for support. Similar to the anchor patch, the sling may be comprised of a flexible, porous material having a frictional surface to prevent slippage. However, such a sling typically comprises two ends, each of which are implanted within the space of Retzius. One end of the sling is deployed within the passageway so that the sling extends from the space of Retzius to one side of the urethra and through the vaginal wall. The other end of the sling is positioned in the same manner through a second passageway on the opposite side of the urethra. Thus, the sling forms a loop underneath the urethra. The sling may then be adjusted to apply tension to the sling and upward force on the urethra. In any case, the portion of the urethral support positioned under the urethra may be covered by the mucosal layer to protect the implanted device and provide a seamless interface for the patient.
Other objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings.